Prescription drug · ANDA
Gabapentin NDC 65862-523
Gabapentin 600 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-523-01 | 6586205230165862052301 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-523-01)Marketed from Oct 6, 2011 | |
| 65862-523-05 | 6586205230565862052305 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-523-05)Marketed from Oct 6, 2011 | |
| 65862-523-26 | 6586205232665862052326 | 2500 TABLET, FILM COATED in 1 BOTTLE (65862-523-26)Marketed from Oct 6, 2011 | |
| 65862-523-90 | 6586205239065862052390 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-523-90)Marketed from Oct 6, 2011 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Gabapentin
- Generic name (nonproprietary)
- gabapentin
- Active ingredients
- Gabapentin — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200651
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65862-523_700d09f5-99cc-492d-ab49-442f674d9c5dSPL ID 700d09f5-99cc-492d-ab49-442f674d9c5dSPL set ID 25cf6c40-a239-4dd0-9cad-28da84d285dbRxCUI 310433, 310434UNII 6CW7F3G59XUPC 0365862524010, 0365862523013
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465862052301followed by a unit qualifier and the quantityPackage 65862-0523-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Gabapentin tablets are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin tablets are indicated for: Postherpetic neuralgia in adults ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 65862-523
- What is NDC 65862-523?
- 65862-523 is the product NDC for Gabapentin, Gabapentin 600 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gabapentin.
- What is the active ingredient?
- Gabapentin.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gabapentin?
- 561 other product NDCs are listed under this name. See all Gabapentin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gabapentin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-943 | 60760-0943-3060760-0943-90 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4763 | 70518-4763-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0581 | 55154-0581-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0595 | 80425-0595-0180425-0595-0280425-0595-03+1 more |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4746 | 70518-4746-0070518-4746-0170518-4746-02+1 more |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 | 70518-4742-0070518-4742-02 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4740 | 70518-4740-00 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0580 | 55154-0580-00 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1233 | 67046-1233-03 |
| Gabapentin | Gabapentin 200 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-231 | 73352-0231-01 |
Other NDCs under ANDA 200651
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6823 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7108 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-330 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-332 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6854 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6855 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3357 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3366 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-148 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2323 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2356 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2616 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2701 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2719 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2765 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2819 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-092 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0036 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0097 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0158 |
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